Ascendis Pharma A/S
Senior Manager, Statistical Programming- Job ID: 1471
Ascendis Pharma A/S, Palo Alto, California, United States, 94306
Are you passionate about leading and supporting statistical programming activities to support drug development?Do you have experience within SAS and CDISC standards, project and resource management?If so, you have the chance to join Ascendis Pharma as our new Senior Manager, Statistical Programming.Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.As our new Senior Manager, Statistical Programming, you will manage internal and external resources to lead or support assigned project statistical programming activities. You will provide programming support to statisticians in the production of summary tables, data listings, and graphs required for clinical trials, and CDISC datasets for regulatory submission.This position requires comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process. The Senior Manager may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. Other responsibilities include but are not limited to managing projects with partner and functional service providers (FSP). The position may be remote and will report directly to the Director, Statistical Programming – Oncology.You will be responsible for:Representing the Statistical Programming team as study lead, focusing on data integrity, collaboration, and on-time deliverables. This work supports our oncology team.Managing and providing oversight of Statistical Programming FTEs, contractors, and CROs.Processing clinical data required for statistical analysis. Develop SAS code and table templates for preparing, processing, and analyzing clinical data.Interacting with members of project teams, statisticians, and data management personnel to establish project timelines and perform statistical analyses.Providing support in the production of summary tables, data listings, and graphs required for trial reports and clinical development, and CDISC datasets for regulatory submission.Managing assigned project programming activities to ensure timely delivery of tables and data listings. Provide guidance and QC/QA standards to ensure the quality of deliverables.You hold a relevant academic degree either as a Bachelor of Science with 10 years of pharma industry experience as a programmer or a Master of Science with 8 years of pharma industry experience as a programmer. You are proficient in English at a professional level, both written and spoken.Furthermore, you have:At least 3 years of experience in managing FTEs, FSPs, and CROs.A minimum of 2 years of experience working with CROs.Prior experience in participation in NDA/BLA submissions.As a person, you are:Demonstrated leadership and excellent interpersonal skills.Exceptional communication skills, with an ability to discuss programming topics with individuals ranging in programming understanding.Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.Ability to multi-task and shift priorities quickly while working under tight deadlines.Preferred:Oncology experience is preferred or a plus.Travel: 5 - 20 days per yearEstimated salary: $175-185K/year DOE
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